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The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring several clinical trials of 2009 H1N1 influenza vaccine in various populations. The trials include people of nearly all ages. They include healthy people as well as individuals with underlying health conditions, specifically, certain people who have asthma or who are HIV-positive. Brief descriptions of these trials, and links for additional information, follow.

Healthy, non-pregnant adults 18 years and older

1. Trial comparing two different strengths and one versus two doses of 2009 H1N1 influenza vaccine produced by Sanofi Pasteur. This trial has enrolled approximately 400 volunteers. Details about the design of this trial are available at NCT00943631.

2. Trial comparing two different strengths and one versus two doses of 2009 H1N1 flu vaccine produced by CSL Limited. This trial has enrolled approximately 400 volunteers. Details about the design of this trial are available at NCT00943488.

3. Trial comparing simultaneous and sequential administration of seasonal flu vaccine and 2009 H1N1 influenza vaccine produced by Sanofi Pasteur. This trial has enrolled approximately 800 volunteers. Details about the design of this trial are available at NCT00943878.

4. Trial testing 2009 H1N1 influenza vaccine produced by Sanofi Pasteur combined with an adjuvant made by GlaxoSmithKline (GSK). (Adjuvants are substances added to vaccine to boost the body’s immune response to the vaccine.) This trial has enrolled approximately 790 volunteers. A Questions and Answers document about this trial is available. Details about the design of the trial are available at NCT00963157.

Healthy children aged 6 months through 17 years old

5. Trial comparing two different strengths and one versus two doses of 2009 H1N1 flu vaccine produced by Sanofi Pasteur. This trial has enrolled approximately 580 children. Details about the design of this trial are available at NCT00944073.

6. Trial comparing simultaneous and sequential administration of seasonal flu vaccine and 2009 H1N1 influenza vaccine produced by Sanofi Pasteur. This trial has enrolled approximately 530 volunteers. Details about the design of this trial are available at NCT00943202. A Questions and Answers document about the trials in children is available.

Healthy pregnant women

7. Trial comparing two different strengths and one versus two doses of 2009 H1N1 flu vaccine produced by Sanofi Pasteur. This trial has enrolled 120 women in the second or third trimester of pregnancy. A Questions and Answers document about this trial is available. Details about the design of this trial are available at NCT 0093430.

8. Trial comparing immune responses of pregnant and non-pregnant women to an inactivated 2009 H1N1 influenza vaccine produced by Novartis. This trial is currently enrolling, and up to 300 women may be enrolled (200 pregnant and 100 non pregnant women). Details about this trial are available at NCT 00992719.

People with asthma

9. Trial comparing two different strengths of 2009 H1N1 influenza vaccine manufactured by Novartis. This trial is cosponsored by NIAID and the National Heart, Lung and Blood Institute (NHLBI). This trila has enrolled 400 people aged 12 years and older who have mild, moderate or severe asthma. All participants have received two doses of vaccine: half of the participants in each group received two 15-microgram doses of vaccine, and the other half received two 30-microgram doses of vaccine. The two doses were administered three weeks apart. A Questions and Answers document about this trial is available. Details about the design of this trial are available at NCT00978120.

Children, youth and pregnant women who have HIV infection

10. Trials testing two doses of 2009 H1N1 vaccine produced by Novartis. These trials are cosponsored by NIAID and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). One trial enrolled 130 HIV-positive pregnant women in the second or third trimester of pregnancy. Details about the design of this trial are at NCT00992017.

One trial enrolled 140 people aged 4 to 24 years old who were infected with HIV at birth. Details about the design of this trial are available at NCT00992836. A Questions and Answers document about these trials is available.

11. Trial comparing two different strengths and one versus two doses of 2009 H1N1 influenza vaccine manufactured by Novartis in HIV-positive adults. This trial is currently enrolling, and up to 240 individuals ages 18-64 may be enrolled.

2.

What key questions are the trials designed to answer?

Confirm the known safety profile of the vaccines in people of various ages, in women who are pregnant, and in people with underlying health conditions, such as asthma or HIV infection?

How large a vaccine dose, and how many doses of vaccine, is needed to induce an immune response that is predictive of protection in these various populations?

Can 2009 H1N1 influenza vaccine be safely administered at the same time or sequentially with the seasonal flu vaccine, and will both vaccines induce protective immune responses?

3.

To date, what have you learned from these trials?

Encouraging preliminary results from some trials have come in and have been announced publicly. The vaccine generally has been found to be safe and well-tolerated, and the vaccine has stimulated immune responses likely to be protective. Specifically, the following information has been announced.

Sept. 11: Healthy adults who received a single 15-microgram dose of 2009 H1N1 vaccine had robust immune responses 8 to 10 days following the first dose of vaccine.

Sept. 21: Healthy children older than 9 years had a robust immune response following a single 15-microgram dose of 2009 H1N1 vaccine. Children 9 years of age and younger are likely to need two doses of vaccine to be protected.

Oct. 9: In healthy adults, co-administration of the seasonal and 2009 H1N1 flu vaccines did not impair the immune response to either vaccine.

Nov. 2: Early results from a trial in healthy pregnant women showed that one dose of 2009 H1N1 vaccine elicits a strong immune response.

4.

Is it possible to become infected with 2009 H1N1 influenza virus by receiving the vaccine?

No. All the 2009 H1N1 vaccines being administered in these trials contain an inactivated (killed) form of the 2009 H1N1 virus. It is impossible to become infected with the virus by receiving the vaccine.

5.

How is the safety of volunteers in these trials being ensured?

Safety is being closely monitored throughout the trials, both by the study investigators and by an independent panel of experts known as a Safety Monitoring Committee. The SMC is convened by NIAID to review the data from all NIAID-sponsored 2009 H1N1 influenza vaccine trials. The committee reviews safety data to look for patterns in the data that would affect the well-being of people in the trial. The committee has the authority to make recommendations to modify or stop trials based on the safety data.

6.

How do scientists evaluate the performance of the vaccines in these trials?

To evaluate the immune response of the vaccines in these trials, the researchers look at the level of antibodies induced by the vaccines in the volunteers using an assay known as the Hemagglutinin inhibition assay (a laboratory test used to measure the amount of antibody present in a human serum by determining if the antibody in the serum is able to inhibit an influenza virus from attaching to red blood cells).

7.

Where are the trials taking place?

The trials in healthy populations (adults, pregnant women and children) are being conducted through the national network of NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs).
There are eight VTEUs located at the following sites:

Baylor College of Medicine, Houston

Children’s Hospital Medical Center, Cincinnati

Emory University, Atlanta

Group Health Cooperative, Seattle

Saint Louis University, St. Louis

University of Iowa, Iowa City

University of Maryland School of Medicine, Baltimore
Vanderbilt University, Nashville

In addition to the eight VTEU locations, some NIAID trials are also enrolling volunteers at additional locations.

Subcontract investigators

Duke University

University of Texas Medical Branch at Galveston

Children’s Mercy Hospital, Kansas City

Stanford University

The NIAID-NHLBI trial of 2009 H1N1 influenza vaccine in people with asthma is enrolling volunteers at seven locations.

Cleveland Clinic, Ohio

Emory University, Atlanta

University of Pittsburgh Asthma Institute

University of Virginia, Charlottesville

University of Wisconsin, Madison

Wake Forest University, Winston-Salem, N.C.

Washington University School of Medicine, St. Louis

The NIAID-NICHD trials of 2009 H1N1 influenza vaccine in HIV-positive children, youth and pregnant women are enrolling volunteers at 43 sites in the United States and Puerto Rico.

Media inquiries can be directed to the NIAID Office of Communications at 301-402-1663, niaidnews@niaid.nih.gov.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of
infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

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